DEXAMETHASONE 6-Day
DEXAMETHASONE TABLETS USP, 1.5 mgTHERAPY PACK 6-DayRx Only
Approved
Approval ID
efaeb61c-ad51-41e7-a2ba-84d8db186ff1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2022
Manufacturers
FDA
Xspire Pharma, Llc
DUNS: 078312042
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEXAMETHASONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42195-721
Application NumberANDA088237
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXAMETHASONE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2022
FDA Product Classification
INGREDIENTS (7)
DEXAMETHASONEActive
Quantity: 1.5 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT